Open Angle GlaucomaPhase 3NCT02914509

Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT

A Phase 3 study testing Travoprost in people with Open Angle Glaucoma and Ocular Hypertension, run by Ocular Therapeutix, Inc. at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of the study is to evaluate evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Open Angle Glaucoma, Ocular Hypertension
What is being tested?: Travoprost
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 565 participants
Where: 10 sitesUnited States
Study dates: 7 Nov 2016to 30 Mar 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Documented diagnosis of ocular hypertension with an open angle of Schaffer Grade 3 or greater or open-angle glaucoma without pseudoexfoliation or pigment dispersion or evidence of traumatic angle recession
IOP is currently controlled as assessed by the Investigator

Who cannot join

Punctum size smaller than 0.4 mm or greater than 0.9 mm in either eye as measured using a standard punctum gauge
A history of an inadequate response or no response to topical prostaglandin
Known or suspected allergy and/or hypersensitivity to travoprost or any prostaglandin, fluorescein, or to any component of the study products

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Study site
Artesia, California
Study site
Austin, Texas
Study site
Cincinnati, Ohio
Study site
Colorado Springs, Colorado
Study site
Des Peres, Missouri
Study site
Lakeland, Florida
Study site
Morrow, Georgia
Study site
Raleigh, North Carolina
Study site
Rochester, New York
Study site
Shawnee Mission, Kansas

Other trials in United States

About this study

Official title: A Prospective, Multicenter, Randomized, Parallel-Arm, Double Masked, Vehicle Controlled Phase 3A Study Evaluating the Safety and Efficacy of OTX-TP in the Treatment of Subjects With Open-Angle Glaucoma or Ocular Hypertension

Read the detailed description

This was a prospective, multicenter, randomized, parallel-arm, double masked, placebo vehicle (PV) controlled study conducted to evaluate the safety and IOP-lowering efficacy of OTX-TP, a sustained release drug product placed in the canaliculus of the eyelid in subjects with open-angle glaucoma or ocular hypertension. A total of up to 550 subjects (1100 eyes) with a clinical diagnosis of open-angle glaucoma or ocular hypertension in both eyes received either OTX-TP or PV to evaluate the safety and efficacy of OTX-TP.

Conditions: Open Angle Glaucoma, Ocular Hypertension
Being tested: Travoprost, Placebo Vehicle
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TravoprostDrug
Placebo VehicleOther

Study groups in NCT02914509
Study group	Role	What they receive
OTX-TP (sustained release travoprost) Intracanalicular Depot	Experimental	OTX-TP (sustained release travoprost) Intracanalicular Depot Receives: Drug: Travoprost
PV (Placebo Vehicle) Intracanalicular Depot	Placebo comparator	PV (Placebo Vehicle) Intracanalicular Depot Receives: Other: Placebo Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean IOP
Measured: Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit
Mean IOP
Measured: Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit
Mean IOP
Measured: Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Nov 201630 Mar 2019

First posted26 Sep 2016 (estimated)
Study start7 Nov 2016
Primary completion30 Mar 2019
Study completion30 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 565 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02914509
Sponsor's protocol ID: OTX-16-002
Status last verified: Sep 2021
First submitted: 21 Sep 2016
Last updated: 11 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Randomized, Parallel-Arm, Double Masked, Vehicle Controlled Phase 3A Study Evaluating the Safety and Efficacy of OTX-TP in the Treatment of Subjects With Open-Angle Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT02914509
Acronym / sponsor ID: OTX-16-002
Conditions: Open Angle Glaucoma, Ocular Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 565 participants (actual)
Lead sponsor: Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
Study start: 7 Nov 2016 (actual)
Primary completion: 30 Mar 2019 (actual)
Study completion: 30 Mar 2019 (actual)
First posted: 26 Sep 2016 (estimated)
Results: Posted 11 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
OTX-TP (sustained release travoprost) Intracanalicular Depot	Experimental	Drug: TravoprostOTX-TP (sustained release travoprost) Intracanalicular Depot
PV (Placebo Vehicle) Intracanalicular Depot	Placebo comparator	Other: Placebo VehiclePV (Placebo Vehicle) Intracanalicular Depot

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Documented diagnosis of ocular hypertension with an open angle of Schaffer Grade 3 or greater or open-angle glaucoma without pseudoexfoliation or pigment dispersion or evidence of traumatic angle recession
IOP is currently controlled as assessed by the Investigator

Key exclusion criteria (3 listed)

Punctum size smaller than 0.4 mm or greater than 0.9 mm in either eye as measured using a standard punctum gauge
A history of an inadequate response or no response to topical prostaglandin
Known or suspected allergy and/or hypersensitivity to travoprost or any prostaglandin, fluorescein, or to any component of the study products

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Travoprost	Drug	OTX-TP (sustained release travoprost) Intracanalicular Depot
Placebo Vehicle	Other	PV (Placebo Vehicle) Intracanalicular Depot

Primary outcome

Mean IOP
Time frame: Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit
Mean IOP
Time frame: Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit
Mean IOP
Time frame: Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit

Results and safety

Results posted to the registry on 11 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OTX-TP	348	343
Placebo Vehicle (PV)	217	211

Primary outcome: Mean IOP

Time frame: Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit. Mean (Standard Error). Unit: mmHg

Measure	OTX-TP (Sustained Release Travoprost) Intracanalicular Depot n = 343	Placebo Vehicle (PV) n = 211
8AM	21 (0.2)	22.9 (0.2)
10AM	20.2 (0.2)	21.9 (0.2)
4PM	19.5 (0.2)	21.5 (0.2)

Primary outcome: Mean IOP

Time frame: Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit. Mean (Standard Error). Unit: mmHg

Measure	OTX-TP (Sustained Release Travoprost) Intracanalicular Depot n = 343	Placebo Vehicle (PV) n = 211
8AM	21.9 (0.2)	26.9 (0.3)
10AM	25.1 (0.2)	25 (0.2)
4PM	24.8 (0.2)	24.6 (0.2)

Primary outcome: Mean IOP

Time frame: Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit. Mean (Standard Error). Unit: mmHg

Measure	OTX-TP (Sustained Release Travoprost) Intracanalicular Depot n = 343	Placebo Vehicle (PV) n = 211
8AM	22.8 (0.2)	23.2 (0.3)
10AM	21.7 (0.2)	22.5 (0.2)
4PM	21.4 (0.2)	22.1 (0.2)

Adverse events

Time frame: through study duration, an average of 23 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OTX-TP (Sustained Release Travoprost) Intracanalicular Depot	7 of 348 (2%)	132 of 348 (37.9%)	1 of 348
Placebo Vehicle (PV)	6 of 217 (2.8%)	65 of 217 (30%)	0 of 217

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Travoprost in people with Open Angle Glaucoma and Ocular Hypertension, run by Ocular Therapeutix, Inc. at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean IOP (time frame: Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02914509.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.